Q-STRESS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-30 for Q-STRESS * manufactured by Mortara Instrument, Inc.

Event Text Entries

[21942398] Patient was exercising on a treadmill during a stress echocadiogram. The patient exercised 10 minutes and 30 seconds. The nurse told the patient that she was going to stop the treadmill and instructed the patient to lie down quickly once the treadmill stopped. The nurse clicked the "stop belt" icon on the screen. The belt paused momentarily and the patient attempted to lie down. The nurse was assisting the patient onto the table when the belt started to accelerate. The patient lost his balance and fell onto the moving treadmill belt. The patient fell onto his right elbow. The nurse also fell at this point in an effort to avoid patient injury. The sonographer hit the two red "stop" buttons on the keyboard. The treadmill belt stopped. The patient was attempting to get up when the belt started to accelerate again. The patient then hit his neck on the treadmill belt. The sonographer then hit the emergency stop button which completely stopped the treadmill belt from moving. The patient was then assisted onto the table by the nurse and sonographer. I was then notified of this event and went into the exam room to assist. I asked the cardiology fellow to come into the stress room to assess the patient. The patient had several abrasions located on his right lower back, hip, right elbow and right neck. The cardiology fellow contacted the attending cardiologist who recommended that we bring the patient to the ed for further assessment. We monitored the patient for approximately 15 minutes post event and then transported him to the ed via wheelchair.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number4226042
MDR Report Key4226042
Date Received2014-09-30
Date of Report2014-09-30
Date of Event2014-09-04
Report Date2014-09-30
Date Reported to FDA2014-09-30
Date Reported to Mfgr2014-11-05
Date Added to Maude2014-11-05
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameQ-STRESS
Generic NameTREADMILL, POWERED
Product CodeIOL
Date Received2014-09-30
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerMORTARA INSTRUMENT, INC
Manufacturer Address7865 NORTH 86TH STREET MILWAUKEE WI 53224 US 53224


Patients

Patient NumberTreatmentOutcomeDate
10 2014-09-30

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